Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06358807

Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus

The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:

* Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score? * Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.

Participants will:

* Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel * Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment * Take MRI preoperatively and 6, 12 and 24 months after surgery

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Osteochondral Lesion of Talus Fractures, Bone Fractures, Stress Microfractures Platelet Rich Plasma Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Location contact

Guo Qinwei

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
  • Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
  • Conservative treatment of at least 3 months fails to relieve symptoms;
  • Willingness to voluntarily participate in the trial and to sign informed consent.

Exclusion criteria

  • Varus or valgus deformity of the ankle of more than 5 degrees;
  • Grade III injury of the lateral collateral ligament of ankle;
  • Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
  • Joint fibrosis, stiffness, and significantly restricted range of motion;
  • Evidence of moderate to severe knee osteoarthritis on plain radiographs;
  • Failure to complete the rehabilitation protocol as required;
  • Patient medically not fit for surgery, radiographs or MRI;
  • For women, pregnant, planning to be pregnant or lactating.

Treatment and study plan

Arthroscopic microfracture with intraoperative local PRP gel injection

Procedure

Arthroscopic microfracture:

An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion.

PRP preparation and local injection:

PRP is harvested using a PRP preparation kit via centrifugation. Fifty milliliters of autologous venous blood are drawn from the patient and processed. Platelet count is measured for quality control. On average 4 ml of (range 3-6) PRP is obtained and mixed with thrombin calcium agent in preparation for PRP gel. PRP gel is administered to the injured area using a blunt and long-tip injector, with direct visualization under arthroscope.

Isolated microfracture

Procedure

Arthroscopic microfracture:

An anteromedial portal and an anterolateral portal are routinely established. A diagnostic arthroscopy is performed. Defects of superficial cartilage, cystic components, and necrotic bone are debrided arthroscopically with curette and shaver to a stable circumferential rim. Microfracture awls are introduced and subchondral channels to 4-6 mm in depth are created, spacing the channels 3 to 5 mm apart across the entire surface of the lesion.

Primary outcomes

  1. American Orthopedic Foot and Ankle Society Score (AOFAS)

    Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery

    The scale of AOFAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery. The primary outcome measure will be the AOFAS collected 24 months post-surgery.

Secondary outcomes

  1. Foot and Ankle Outcome Score (FAOS)

    Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery

    The scale of FAOS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.

  2. Ankle Activity Score (AAS)

    Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery

    The scale of AAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.

  3. Visual Analogue Scale (VAS)

    Time frame: Pre-surgery and 3, 6, 12 and 24 months after surgery

    The scale of VAS score will be answered by participants during clinic follow-up preoperatively, and 3, 6, 12 and 24 months after surgery.

  4. Patient Satisfaction

    Time frame: Final follow-up (24 months after surgery)

    Patient satisfaction will be graded as 0-10 and collected 24 months after surgery.

  5. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)

    Time frame: Twelve and 24 months after surgery

    MOCART score will be assessed on magnetic resonance imaging 12 and 24 months after surgery.

  6. Return-to-Sport Rate

    Time frame: Final follow-up (24 months after surgery)

    The rate and time point of participants returning to sports will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery.

  7. Complications

    Time frame: Final follow-up (24 months after surgery)

    Complications, including infection,hematoma, stiffness, recurrent ankle pain will be continuously followed during clinic follow-up and will be overall collected 24 months after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Fengyi Hu, MD

CONTACT

[email protected]

+86 13335511505

Qinwei Guo, MD

CONTACT

[email protected]

+86 18601129252

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Clinical Efficacy of Arthroscopic Microfracture Combined With Local Injection of Platelet Rich Plasma Gel in Treatment of Osteochondral Lesion of the Talus: A Randomized Control Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.